CPCSEA ppt final (S S C)

CPCSEA GUIDELINE FOR LABORATORY ANIMAL CARE AND HANDLING.....

1. PRESENTED BY: S.S.CHAUDHARI
(M.PHARM 1
ST
SEMISTER)

DEPARTMENT OF PHARMACOLOGY
R C PATEL COLLEGE OF
PHARMACY
SHIRPUR
CPCSEA GUIDELINES FOR
LABORATORY ANIMAL CARE AND
HANDLING

2. What Are The Animal Laws?
2
The Constitution of India
The Indian Penal Code, 1860
The Criminal Procedure Code, 1973
The Prevention of Cruelty to Animals Act, 1960
The Wildlife Protection Act, 1972
The Police Acts
The Municipal Corporation Acts.

3. GOAL
(1)
3
To promote the humane care of animals used in
biomedical and behavioral research and testing.
To provide specifications that will enhance animal well
being.
To provide quality in gaining advanced biological
knowledge that is relevant to humans and animals

4. GUIDELINES
(1,2,3,4)
4
VETERINARY CARE
Adequate veterinary care must be provided and is the
responsibility of a veterinarian.
Daily observation.

5. ANIMAL PROCUREMENT
5
All animals must be acquired lawfully as per the CPCSEA
guidelines.
A health surveillance program for incoming animals
should be carried out to assess animal quality.
 Inspect for compliance with procurement specifications.

6. QUARANTINE
6
An effective quarantine minimizes the chance for
introduction of pathogens into an established colony.
 A minimum duration of quarantine
- Small lab animals - 1 week and
- Larger animals - 6 weeks

7. STABILIZATION AND SEPARATION
7
Newly received animals should be given a period for
physiologic, psychologic and nutritional stabilization
before their use.
Duration for stabilization will depend on the type of
animal, transportation and intended use.
Physical separation of animals by species is
recommended.

8. SURVEILLANCE, DIAGNOSIS,
TREATMENT AND CONTROL OF DISEASE
8
Observe for signs of illness, injury, or abnormal behavior.
Unexpected deaths and signs of illness should be
reported.
If animals are known to be exposed to an infectious
agent the group should be kept intact and isolated during
the process of diagnosis, treatment, and control.
Diagnostic clinical laboratory may be made available.

9. ANIMAL CARE AND TECHNICAL PERSONNEL
9
Employ people trained in laboratory animal science.

They should be provide for both formal and on-the-job
training.

10. 10
Annexure – 7
CERTIFICATE COURSE FOR
LABORATORY
ATTENDANT
(Basic Education: 8
t h
standard)
Introduction
Animals rooms
Handling of animals
Personal hygiene
Emergency situations

11. PERSONAL HYGIENE
11
It is essential to maintain a high standard of
personal cleanliness.
Decontaminate clothing exposed to potentially
hazardous microbial agents or toxic substances.
Use disposable gear.
No permission to eat, drink, smoke or apply
cosmetics in animal rooms.

12. ANIMAL EXPERIMENTATION INVOLVING
HAZARDOUS AGENTS
12
Institutional Biosafety Committee.
The procedures must be reviewed by both the Institutional
Biosafety committee and Institutional Animal Ethics
Committee (IAEC).
(Annexure – 8)

13. Annexure – 8
13
Institutional Biosafety Committee
(IBSC)
Institutional Biosafety Committee (IBSC) is to be
constituted in all centers engaged in genetic
engineering research and production activities.
 The Committee will constitute the following.
(i) Head of the institution or his nominee
(ii) 3 or more scientists engaged in DNA work or molecular
biology with an outside expert in the relevant
discipline.
(iii) A member with medical qualification- Biosafety officer
(in case of work with pathogenic agents/large scale
used.)
(iv) One member nominated by DBT

14. MULTIPLE SURGICAL PROCEDURES ON SINGLE
ANIMAL
14
Multiple surgical procedures not to be practiced unless
specified in a protocol only approved by the IAEC.
DURATIONS OF EXPERIMENTS
No animal should be used for experimentation for more
than 3 years unless adequate justification is provided.

15. PHYSICAL RESTRAINT
15
Brief physical restraint can be accomplished manually or
with devices.
Prolonged restraint of any animal should be avoided unless
essential to research objectives.

Less restrictive systems, such as the tether system or the
pole and collar system should be used when compatible
with research objectives.

16. The following are important guidelines
for the use of restraint equipments:
16
Not be used simply as a convenience in handling or
managing animals.
Minimum time.

Should be given training to adapt to the equipment.
Observe the animal at appropriate intervals.
Veterinary care should be provided if lesions or illness
associated with restraint are observed.

17. PHYSICAL PLANT
17
The physical condition and design of animal facility should
be well planned and properly maintained.
PHYSICAL RELATIONSHIP OF ANIMAL
FACILITIES TO LABORATORY
Isolated far away from human habitation.
Place animal housing areas adjacent to or near laboratories
but separated

18. FUNCTIONAL AREAS
18
Sufficient animal area required to:
Ensure separation of species or isolation of individual
projects when necessary;
Receive, quarantine, and isolate animals;
Provide for animal housing.

19. PHYSICAL FACILITIES
19
(1)Building material (7) Corridor
(2)Animal room doors (8) Exterior windows
(3)Floors
(4)Drains
(5)Storage areas
(6)Experimental area

20. ENVIRONMENT
20
(a) TEMPERATURE AND HUMIDITY CONTROL
18 to 29°C temperature range
30% to70% relative humidity
(b) VENTILATION

21. (c) POWER AND LIGHTING
21
A time-controlled lighting system
 Emergency power should be available in the event of
power failure
(d) NOISE CONTROL

22. ANIMAL HUSBANDRY
22
(a) CAGING OR HOUSING SYSTEM:
Provide adequate space
Comfortable environment
Escape proof enclosure that confines animal safety
Easy access to food and water;
Provide adequate ventilation
Meet the biological needs of the animals
Keep the animals dry and clean

23. Annexure – 3A
Minimum floor area recommended for laboratory
animals (based on their weight/size and behavioral
activity)
23
Animal Weight in Floor area Cage height
gram (cm
2
) (cm)
MICE <10 38.7
upto15 1.6
upto25 7.4
>25 96.7 12
RATS <100 109.6
upto200 148.3
upto300 187.0
upto400 258
upto500 387
>500 >=451.5 14

GUINEA PIG <350 387
>350 >=651.4 18
HAMSTERS <60 64.5
upto80 83.8
upto100 103.2
>100 122.5 12

24. 24
(b) SHELTERED OR OUTDOOR HOUSING:
Accessible to all animals, sufficient ventilation, and prevent
build up of waste materials and excessive moisture.
(c) SOCIAL ENVIRONMENT:
Whether the animals are naturally territorial or communal.
FOOD
Animals should be fed palatable, non-contaminated, and
nutritionally adequate food daily.

25. BEDDING
25
DESIRABLE CRITERIA
Absorbent
Free of toxic chemicals
Ammonia binding
Sterilizable
Easily stored
Uncontaminated
Nontoxic
Disposable by incineration
Readily available

26. WATER
26
Continuous access of fresh, potable, uncontaminated
drinking water.
Periodic monitoring of microbial contamination.
SANITATION and CLEANLINESS
Cleaning with detergents and disinfectants.
Wire – bottom rodent cages should be washed at least
every 2 weeks.
Disinfection of cages by rinsing at a temperature of 82.2
0
C
(180 F).

27. WASTE DISPOSAL AND PEST CONTROL
27
Remove regularly and frequently.
Animal tissues, carcasses, and hazardous wastes should
be lined with leak – proof, disposable liners.
EMERGENCY, WEEKEND AND HOLIDAY
CARE
Animals should be cared by qualified personnel every day,
including weekends and holidays.

28. RECORD KEEPING
28
The Animal House should maintain following records:
 Animal House plans
 Animal House staff record
 All SOPs for animals
 Breeding, stock, purchase and sales records
 Minutes of institutional Animals Ethics Committee
meetings
 Records of experiments
 Death Record
 Clinical record
 Water analysis report

29. STANDARD OPERATING PROCEDURES (SOPs)
29
The Institute shall maintain SOPs describing procedures /
methods of
Animal Husbandry
Maintenance
Breeding
Animal house microbial analysis
Experimentation records.

30. 30
TRANSPORT OF LABORATORY ANIMALS
The main considerations for transport of animals are:
Mode of transport
Containers
Animal density in cages
Food and water during transit
 Protection from transit infections
 Injuries and stress

31. ANNEXURE – 4
REQUIREMENTS FOR TRANSPORT OF LABORATORY
ANIMALS BY ROAD, RAIL AND AIR
SpeciesSpeciesMouse Rat Hamster G.Pig Rabbit Cat Dog Monkey
Max. no
of
animal/
cage
25 25 25 12 2 1 or 21 or 2 1
Material
used in
transp-
ort
Metal
Cardboard
,Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
Metal
Cardboard,
Synthetic
material
MetalMetalBamboo/
wood/
metal
Space/
animal
(cm
2
)
20-25 80-100 80-100 80-100 1000-12001400-
1500
3000 2000-
4000
Min.
height of
box (cm)
12 14 12 15 30 40 50 48
31

32. ANAESTHESIA
(4)
32
Sedatives, analgesics and anaesthetics should be used to
control pain or distress under experiment.


NARCOSIS
RELAXATION ANALGESIA

33. ANNEXURE – 5
COMMONLY USED ANAESTHETIC DRUGS FOR
LABORATORY ANIMALS
Drugs
(mg/kg)
MouseRat HamsterRabbit Cat Dog Monkey Guinea pig
KETAMI
-NE
22-24
i/m
22-24
i/m
-- 22-24 i/m30 i/m 30 i/m 15-40 i/m 22-24 i/m
PENTO-
BARBIT
ONE
35 i/v
50 i/p
25 i/v
50 i/p
35 i/v
-
30 i/v
40 i/p
25 i/v
-
20-30 i/v
-
35 i/v
-
30 i/v
40 i/p
THIOPE
NTONE
SODIUM
25 i/v
50 i/p
20 i/v
40 i/p
20 i/v
40 i/p
20 i/v 25 i/v
-
25 i/v
-
25 i/v
60 i/p
20 i/v
55 i/p
URETHA
NE -
0.75 i/p
-
0.75 % 1.25 i/v
1.50 i/p
1.0 i/v1.0 i/v 1.5 i/p
33

34. EUTHANASIA
34
(a) Death, without causing anxiety, pain or distress with
minimum time lag phase.
(b) Minimum physiological and psychological disturbances.
(c) Compatibility with the purpose of study and minimum
emotional effect on the operator.
(d) Location should be separate from animal rooms and
free from environmental contaminants.

35. ANNEXURE – 6
EUTHANASIA OF LABORATORY ANIMALS
(A – Methods Acceptable for species of animals indicated NR – Not
Recommended)
Species Mouse Rat Hamster Guinea
pig
RabbitCat Dog Monkey
a) PHYSICAL METHODS
Electrocution
Exsanguination
Decapitation
Cervical dislocation
NR
NR
A
A
NR
A
A
A
NR
A
A
A
NR
A
NR
NR
NR
A
NR
NR
NR
A
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
b) INHALATION OF
GASES
Carbon mono oxide
Carbon di oxide
CO2+Chloroform
Halothane
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
NR
NR
A
A
NR
NR
A
c) DRUG
ADMINISTRATION
Barbiturate overdose
Chloral hydrate overdose
Ketamine overdose
Sodium Pentothol
(IP)
NR
IM/IP
IP
(IP)
NR
IM/IP
IP
(IP)
NR
(IM/IP)
IP
(IP)
NR
IM/IP
IP
IV,IP
IV
IM/IV
IV
IV,IP
IV
IM
IV
IV,IP
IV
IM
IV
IV,IP
IV
IM/IV
IV
35

36. LABORATORY ANIMAL ETHICS
36
All scientists working with laboratory animals must have a
deep ethical consideration for the animals they are dealing
with.
TRANSGENIC ANIMALS
Transgenic animals are those animals, into whose germ
line foreign gene(s) have been engineered.
Knockout animals are those whose specific gene(s) have
been disrupted leading to loss of function.

37. MAINTENANCE
37
Special care has to be taken with transgenic/gene knockout
animals
Prevent cross breeding with other animals.
Knockout animals should be maintained in clean room
environment or in animal isolators.
DISPOSAL
The transgenic and knockout animals should be first
euthanized and then disposed off.

38. 38
BREEDING AND GENETICS
For initiating a colony, the breeding stock must be
procured from CPCSEA registered breeders or suppliers.

39. 39
Experimentation on animals in course of medical
research and education is covered by provisions of the
Prevention of Cruelty to Animals Act, 1960 and the
Rules under the Act of 1998 and 2001.
(10)
The Prevention of Cruelty to Animals Act, 1960 provided
for constitution of CPCSEA
(11)
The Experiments on Animals (control and supervision)
Amendments Rules (1998) gave power to CPCSEA to
make rules.
(11)

40. OPERATIONAL GUIDELINES IN CPCSEA
(10)
40
Main activities
(a) Registration of establishments for Breeding of animals:

(b) Registration of establishments for experiments on
animals:
(c) Approval of Animal House Facilities:
(d) Permission of Committee for Conducting Experiments:
(e) Recommendation for import:

41. 2. Regulatory Mechanism :
41
2.1 Committee for the Purpose of Control and
Supervision of Experiments on Animals
(CPCSEA)
To ensure that animals are not subjected to unnecessary
pain or suffering before, during or after performance of
experiments on them.
2.2 Sub-Committees of the CPCSEA :
1) Sub-Committee on Large Animals (SCLA).
2) Sub-Committee for selection of CPCSEA Nominees on
Institutional Animals Ethics Committees.

42. 2.3 Institutional Animal Ethics Committee (IAEC)
42
Every establishment is required to constitute an
Institutional Animal Ethics Committee.
Every IAEC shall include;
A biological scientist,
Two scientists from different biological disciplines,
A veterinarian involved in the care of animals,
A scientist in charge of animals facility of the
establishment concerned,
A scientist from outside the institute,
A non-scientific socially aware member and
A representative or nominee of the CPCSEA.
A specialist may be co-opted while reviewing special
projects.

43. KEY ROLE
43
To assess proposal to use animal for scientific purposes,
including teaching and decide whether
1)The use is justified
2)Welfare of animal is protected
FOR ANIMAL USE TO BE JUSTIFIED,THE AEC MUST
Be convinced that the benefits from the use outweigh the
potential costs to the animal
Be assure that ‘3 Rs’ of the animal use must be justified

44. 2.4 Member Secretary, CPCSEA :
44
Member Secretary, is responsible for registration of
establishment engaged in Breeding of Animals and also
in Experimentation on Animals.
Application for permission for conducting experiments are
brought before the CPCSEA and SCLA by MS.
He has also been authorized to constitute the Inspection
Teams for inspection of Animal House Facilities.

45. 3. Standing time tables of meetings of the
regulator/expert body:
COMMITTEES
 CPCSEA
SCLA
IAEC
Sub-Committee for selection of
CPCSEA Nominees on IAEC
Member Secretary, CPCSEA
DAYS
Quarterly as on 20
thDec, 20
th
March, 20
th June, 20
th Sep
10
thof every alternate month
Vary as per need
Once in 6 month
No requirement of time table
45

46. 4. Nomination of Co-chair/Vice chair of the
regulator/expert body for presiding over the
meeting in the absence of the chair
46

47. 47
5. Ground Rules :
(1)Registration of establishment for Breeding of animals &
for experiments of animals:
The Member-Secretary would take a decision on any
application for Registration within two months of its
receipt.
Incase the application can not be decided within two
months, it will be brought to the notice of CPCSEA at
its ensuing meeting.

48. 48
(i) The application should be accompanied by a bank draft of
Rs.1,000/- in favor of CPCSEA as registration fee.
(ii) The establishment should have constituted an IAEC
before applying for registration.
(iii) Before taking the decision regarding Registration, a spot
inspection of the organization would be necessary.

49. (ii) Approval of Animal House Facilities:
49
(a) Detailed inspection by a Inspection team. As per the
existing practice the following is the composition of
inspection team:
(i) CPCSEA’s Nominee
(ii) Expert Consultant, CPCSEA
(iii) Person in charge of another animal house in the same
State, where the institution carrying out experiment is
located.

50. (iii) Permission of Committee for Conducting
Experiments
50
(a) No proposal for Animal Experimentation would be
entertained, unless the Animal House Facility of the
concerned establishment has been approved by
competent authority.
(b) The approval for experimentation on small animals will be
accorded by IAEC.

(c) Approval for experimentation on Large Animals will be
considered by SCLA on the recommendation of IAEC.

51. PRINCIPLES FOR UTILIZATION AND CARE OF ANIMALS TO
BE USED IN TESTING, RESEARCH AND TRAINING
51
Principle No.1
“Experiments on animals” (including experiments involving
operations on animals) may be carried out for:
The purposes of advancement by new discovery

Knowledge which is expected to be useful for saving or for
prolonging human life or alleviating suffering

For combating any disease, whether of human beings,
animals or plants

52. 52
Principle No.2.
Animals lowest on the phylogenetic scale which may give
scientifically valid results should be used for any experimental
procedure.
Experiments should be designed with the minimum number of
animals to give statistically valid results at 95% level of
confidence.
Alternatives not involving animal testing should be given due
and full consideration and sound justification provided if
alternatives, when available, are not used.
“Cockroach“ (Invertebrates) < Birds < Rodents <
Canines < Bovine/Equines <Primates (e.g. Rhesus
macaque)< More evolved Primates (e.g. chimpanzee)

53. Principle No.3
53
Proper use of animals in experiments and avoidance or
minimization of pain and suffering inflicted on
experimental animals should be an issue of priority for
research personnel.
All scientific procedures that may cause more than
momentary or slight pain and/or suffering should be
performed with appropriate sedation, analgesia or
anesthesia.

54. Principle No.4
54
Persons engaged in animal experimentation have a
moral responsibility for the welfare of the animals after
their use in experiments.
Principle No.5
The living conditions of animals should be appropriate for
their species and contribute to their health and comfort.

55. REFERENCES
55
(1) Committee for the purpose of control and supervision on
experiments on animals, CPCSEA guidelines for laboratory animal
facilities, Chennai: 3-36.
2) Goyel R K., et al.(2006) Different laboratory animals and their
applications, Practical in pharmacology, B.S.Shah prakashan,6:7-
29.
3) Kulkarni S K, Common laboratory animals (1999) Handbook of
experimental pharmacology, Vallabh prakashan, Delhi 3:11-18.
4) Wolfensohn Sarah, Lloyd Maggie. (2000) Introduction to the
principles of animal care and use. Handbook of laboratory animal
management and welfare 1:55-69

56. 56
5) Foster H L., Small J D., Fox J G.(1982) The mouse in biomedical research,
experimental biology & oncology, Academic press ,London 2:1-9
6) Waynforth H B., Flecknell P A.(1999) Administration of substance, anaesthesia &
post operative care Experimental and surgical technique in rat, Academic press,
London,2:1-147
7) McLeod L J., Pharmacological experiments on intact preparations. Edixrurgh &
London:1-32

8)Vogel H G.,(2000) Anesthetics, Drug discovery and evaluation In pharmacological
assays, Springer. 2:587-658.

57. 57
9)Report of consultative group review of the norms and
practices for regulation of animal experimentation
(2004), Ministry of environment and forest, Govt. of
India:1-18
10) Operational guidelines for observance of good
practices in CPCSEA:1-11
11)Subramoniam A., Gitanjali B.,(2003) CPCSEA- A double
edged sword, Indian Journal of Pharmacology 35: 71-
72

58. QUESTIONS
58
1)Discuss about CPCSEA regulations for laboratory animal
care.
2)CPCSEA regulations for animal care.
3)Discuss the regulations for laboratory animal care and
ethical requirements.

59. 59